drugset / Trial / NCT07018206

Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis

NCT07018206

Phase 4 Not yet recruiting 200 enrolled CARE ARTHRITIS LTD.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase IV, open-label, multicenter study evaluating the impact of upadacitinib on the frequency of acute anterior uveitis (AAU) in adults with axial spondyloarthritis (axSpA) and a documented history of AAU in the prior 52 weeks. Approximately 200 participants will be enrolled across North America and Europe, including both biologic DMARD-inadequate responders (bDMARD-IR) and bDMARD-naïve patients. The primary objective is to assess the change in exposure-adjusted AAU event rate during 52 weeks of treatment with upadacitinib 15 mg once daily. Secondary objectives include evaluating the effect of upadacitinib on disease activity, pain, physical function, quality of life, and sleep. Safety and tolerability will also be assessed throughout the study.

Timeline

Start
2026-05
Primary completion
2027-05
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Upadacitinib Small molecule 15 mg Oral

Indications